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Expert Advisory Group on Bioavailability and Bioequivalence Studies

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Functions

The Expert Advisory Group on Bioavailability and Bioequivalence ("BABE") Studies is set up under the Pharmacy and Poisons Board to :

(a) provide the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee ("Registration Committee") with professional advice on the implementation plan of requiring BABE studies as a registration requirement for generic drugs by phases;
(b) provide professional support to the Registration Committee on issues relating to BABE studies;
(c) provide expert opinion on the methodology and protocol of BABE studies proposed by applicants of pharmaceutical product registration; and
(d) provide expert opinion on the study data submitted by applicants of pharmaceutical product registration.

Membership

Chairman
  • Mr CHAN Ling-fung, Frank, JP
Members
  • Dr CHENG, Celine
  • Prof CHEUNG Man-yung, Bernard
  • Dr FAN Yuen-man, Cecilia
  • Prof JOHNSTON, Atholl
  • Prof LAM Ching-wan
  • Prof LEE Wing-yan, Vivian
  • Mr LING Ho-ming, Michael
  • Prof LUK On-yan, Andrea
  • Prof SMITH, David
  • Prof WONG Chi-kei, Ian
  • Mr WONG Yik-cheong, Anthony
  • Ms YUEN, Karen
  • Prof ZUO Zhong, Joan
Secretary
  • Mr YEUNG Yee-fai, Raphael
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